Director of Regulatory Affairs

Executive (SVP, VP, Department Head, etc) Education Level: Bachelor's Degree Company: Synerfac Technical Staffing Contact: Evan Seltzer Email: Apply by Email Phone: 410-667-3949 Website: www.synerfac.com Director of Regulatory Affairs Job Title:   Director of Regulatory AffairsLocation:  Baltimore, MDSalary:  100-140kOur client is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. They specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.Responsibilities: The selected candidate will be responsible for compiling and processing US IND, CTD, Annual reports, DMF, NDA and BLA submissions and assisting with all Regulatory Affairs /Quality Assurance department needs.  In this role, you will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with staff in resolving regulatory issues and/or problems. Ensure that the company adheres to all applicable regulations.  Serve as the team member for specific projects; be responsible for gathering and entering regulatory information related to specific projects; perform regulatory and/or quality assurance reviews of data or reports; attend project meetings, professional meetings, seminars and workshops; and document all phases of involvement in any specific projectRequirements:  The qualified candidate will have a bachelor’s degree in the life sciences or equivalent 10 years of experience in the pharmaceutical or CRO industry with at least 3 of these years as a regulatory affairs Manager or higher level The candidate must be experienced in writing and compiling regulatory documents (i.e. (INDs, NDAs, BLAs, DMFs, FDA meeting packages, IBs, etc.) Hands-on strategic regulatory planning experience is preferred Excellent attention to detail, written and verbal communication and computer skills are required Very strong communication skills Ability to lead/manage 3 to 4 individuals Experience in the pharmaceutical or CRO industry importantEducation Preferred: GED or High School DegreeContact Information:Evan SeltzerSr. Staffing CoordinatorSynerfac Technical StaffingPhone:  (410)667-3949Fax:  (410)667-3950E-mail:  eseltzer@synerfac.com